Dear AuntMinnie Member,
If you used a metal filing cabinet to store patient images, would you consider it a medical device requiring FDA clearance? Probably not. But ask the same question about a PACS archive and the answer is less clear.
Unfortunately for PACS users, the question goes beyond semantics. Confusion over the regulatory status of PACS storage technology has ensnared many medical facilities looking to upgrade their archives.
Many sites refrain from installing third-party archive technology because these systems don’t have their own FDA clearances. As a result, PACS users are locked into using whatever archives are offered by their primary PACS provider.
This will change, however, thanks to a recent FDA opinion on PACS archives. In an article we're featuring in our PACS Digital Community, healthcare consultants Stuart C. Gardner and Kris K. Hughes from SG&A Consulting describe why facilities should now have more freedom to select the archive of their choice.
Gardner and Hughes believe the guidance could help imaging sites save millions in archiving costs as they switch to more cost-effective storage options. Learn all about it in our PACS Digital Community, at http://pacs.auntminnie.com.
